(112 days)
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, document, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
The TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P has been designed to be used with an Olympus video system center, documentation equipment, display monitor and other ancillary equipment for airway management, which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
The VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V has been designed to be used with an Olympus video system center, light source, documentation equipment, display monitor, suction pump, and other ancillary equipment for airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI-powered device.
Instead, the document is a 510(k) premarket notification summary for two tracheal intubation fiberscopes/videoscopes (OLYMPUS LF-P and VISERA LF Type V). This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and non-clinical bench testing, rather than a clinical study of an AI device meeting specific performance criteria.
Therefore, I cannot provide the requested information from the given input.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.